Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

A Woman Relegated To The Manufacturing Night Shift

After graduating with a biology degree from Howard University and entering the pharma industry, Stephanie Wimberly found herself the only woman — the only black woman — in a manufacturing facility in Maryland. A supervisor made it clear he didn’t want her on his team; she was reassigned to the night shift at her facility. “I had a family to support, and night shift, or abuse, was not what I signed up for,” she says. “But I didn’t have many options.” Here is how she persevered, and prospered.

GUEST COLUMNISTS

Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.
The Real Reason We Haven't Fully Automated Cell Therapy Yet
Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.
The Firefighting Era Of Clinical Supply Chain Is Over. Here's What Replaces It
Clinical trial supply chains are evolving: digital twins, on-demand kits, and sustainable logistics replace reactive firefighting with precision, speed, and resilience.
The Hidden Engineering Behind Successful Upstream Bioprocessing
In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.
A Practical Look At Modern Downstream Processing For Biologics
Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.
Process Engineering's Key Role In Sterile Injectable Facility Design
Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.
What To Know About — And How To Apply For — FDA's PreCheck Pilot
FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.

PHARMA OUTSOURCING WHITE PAPERS

Operational Success By Strategic Investment
Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.

Optimizing Charge And N-glycan Profiles For CHO-Derived Fusion Proteins
Discover how structured design-of-experiment approaches can optimize charge variants and glycosylation to enhance biologics quality and therapeutic performance.
Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy
The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
Boosting CMC Regulatory Efficiency In Gene Therapy
Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.
Engineering Reliability In Cell Therapy Manufacturing
A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.
Key Selection Criteria For Cell & Gene Therapy CDMOs
Choosing the right CDMO requires early internal assessment plus strong technical capability, agility, advocacy, clear communication, and long‑term alignment to meet evolving cell and gene therapy needs.